MAUDE Adverse Event Report: BECTON DICKINSON KIT UVT 3ML WITH FLOCKED MINITIP; CULTURE MEDIA

Model Number	220529
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Oem manufacture: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd (b)(6) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.(b)(4).
Event or Problem Description
The customer reported while using the kit uvt 3ml with flocked minitip to collect a sample the tip of the swab broke off in the patients nose.The patient was sent to the emergency room for follow-up, and removal of the swab.The patient was released with no further issues or treatment needed.
Additional Manufacturer Narrative
Investigation summary: the customer complaint is not confirmed.A review of the retention samples and dhr did not indicate any issues that would contribute to this defect.A physical stressing of the retention samples revealed that the swabs are within specification.No physical samples were available.A review of past complaints for this product does not indicate a trend on this issue.
Event or Problem Description
The customer reported while using the kit uvt 3ml with flocked minitip to collect a sample the tip of the swab broke off in the patients nose.The patient was sent to the emergency room for follow-up, and removal of the swab.The patient was released with no further issues or treatment needed.

• Brand Name: KIT UVT 3ML WITH FLOCKED MINITIP
• Common Device Name: CULTURE MEDIA
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10278600
• Report Number: 2243072-2020-01069
• Device Sequence Number: 11024382
• Product Code: JSM
• UDI-Device Identifier: 30382902205297
• UDI-Public: 30382902205297
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K042970
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 08/31/2021
• Device Model Number: 220529
• Device Catalogue Number: 220529
• Device Lot Number: 200314400
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other